fit-for-purpose quality control protocols for biologics and nucleic acid therapeutics

Designing “fit-for-purpose” quality control protocols for biologics and nucleic acid therapeutics

The rapid maturation of nucleic acid therapeutics and complex biologics has necessitated a significant shift in the pharmaceutical quality paradigm. Traditional “one-size-fits-all” approaches are increasingly inadequate for modalities like messenger RNA (mRNA), antisense oligonucleotides, and viral vectors, where the structural…